The vast majority of patients with pancreatic cancer are diagnosed with locally advanced unrespectable or advanced disease for which there is no curative therapy. Many chemotherapeutic agents have been evaluated in patients with pancreatic cancer. Gemcitabine (gem) and 5-FU are the most commonly used agents. The combination of gem and 5-FU has been noted to have a marked synergistic cytotoxic effect against pancreatic cancer cells in "in vitro" assays.

Materials and Methods:

A total of 327 patients with advanced pancreatic carcinoma were included in this randomized study.

The response rate was 5.6% in gem alone arm and 6.9% in gem + 5-FU arm.

Both treatment groups were well tolerated.

The median survival was 5.4 months on gem + 5-FU and 6.7 months for patients on gem alone (p=0.09).

The overall survival was the same between two groups.

Older age and poor performance status were associated with poorer prognosis.

Authors' Conclusions

The combination of gem and 5-FU did not produce a significant increase in survival for patients with advanced pancreatic carcinoma. The addition of 5-FU to gem did not add more toxicity.

Clinical/Scientific Implications:

Pancreatic adenocarcinoma is traditionally considered a chemoresistant tumor because of the low response rate; in addition, the median duration of survival has been generally less than 6 months. New active agents or chemotherapy regimens are needed to improve patients' quality of life and survival.